Shockwave IVL for TAVR Access Site Complications

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Tennessee Graduate School of Medicine

Disqualifiers: Cognitive impairments, Unfavorable calcium distribution

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Day 0

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to reduce complications during Transcatheter Aortic Valve Replacement (TAVR) in patients with heavily calcified femoral arteries (arteries in the thigh hardened with calcium). The trial uses a device called the Shockwave M5 IVL Catheter to improve access to these arteries. It compares this new method to the standard procedure to determine which is more effective. Individuals with severe aortic stenosis (a serious heart valve problem) who plan to undergo TAVR, especially if their thigh arteries are heavily calcified, might be suitable for this study.

As an unphased trial, this study provides a unique opportunity to contribute to medical advancements in TAVR procedures.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Shockwave M5 IVL Catheter is safe for TAVR access site complications?

Research has shown that the Shockwave M5 Intravascular Lithotripsy (IVL) device is safe for patients with very hard deposits in their arteries. Studies have found it to be a well-tolerated treatment, especially for those needing procedures like Transcatheter Aortic Valve Replacement (TAVR). In one study, procedures using IVL proved both safe and effective for patients with significant artery calcifications. Another study reported a high success rate of 99%, indicating the procedure was completed successfully almost every time. This suggests that the treatment is reliable and rarely causes major problems. Overall, the Shockwave M5 IVL device has demonstrated effectiveness and safety for these types of procedures. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using the Shockwave M5 Intravascular Lithotripsy (IVL) for TAVR access site complications because it offers a unique approach to dealing with heavily calcified femoral arteries. Unlike standard procedures that rely solely on mechanical and surgical techniques, the Shockwave IVL device uses sound waves to gently break up calcium deposits in the arteries, making them more pliable for catheter insertion. This method potentially reduces the risk of complications and improves outcomes by enhancing the safety and success of femoral artery access, which is crucial in procedures like TAVR.

What evidence suggests that the Shockwave M5 IVL Catheter is effective for reducing access site complications in TAVR?

In this trial, participants will receive treatment with either the Shockwave M5 IVL Catheter or standard femoral access. Studies have shown that the Shockwave M5 IVL Catheter effectively breaks down calcium build-up in arteries, aiding doctors in accessing the arteries through the leg—an important step for the TAVR heart procedure. Research indicates a very high success rate, with 99% of problem areas in arteries successfully treated using this method. Specifically, patients who received the Shockwave IVL treatment demonstrated better artery access compared to those who did not. This suggests that using the Shockwave M5 IVL Catheter could reduce complications during the procedure. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for patients with heavily calcified arteries who need a Transcatheter Aortic Valve Replacement (TAVR) procedure. Specific details on eligibility criteria are not provided, but typically participants would have conditions like Aortic Stenosis or Von Willebrand Disease.

Inclusion Criteria

Participants must be able to read and understand study procedures

Willing to participate and sign an ICF

Patients with >90-degree arc of calcium at the large bore access site per CT documentation

Exclusion Criteria

Unable to understand study procedures

Unwilling to give consent

I can make decisions about my health care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Transcatheter Aortic Valve Replacement (TAVR) with or without Shockwave Intravascular Lithotripsy (IVL) for femoral artery access

Day 0

1 visit (in-person)

Immediate Post-Procedure Monitoring

Participants are monitored for clinical deterioration, including changes in hemoglobin, serum creatinine, and incidence of hypotension or shock

3 days

Follow-up

Participants are monitored for safety and effectiveness, including hospital length of stay, mortality, and complications

Up to 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Shockwave M5 IVL Catheter

Trial Overview The study tests if using the Shockwave M5 IVL Catheter to treat the artery before inserting a large tube (sheath) reduces complications compared to the standard Modified Seldinger Technique during TAVR procedures.

How Is the Trial Designed?

Group I: Shockwave model (M5) Intravascular Lithotripsy (IVL) Experimental Treatment 2 Interventions

Patients will be treated with the Shockwave M5 Intravascular Lithotripsy (IVL) device prior to femoral artery access using the modified Seldinger technique

Group II: Standard femoral access Active Control 1 Intervention

Patients will receive standard femoral artery access via the modified Seldinger approach without utilizing intravascular lithotripsy in heavily calcified femoral arteries

Who Is Running the Clinical Trial?

University of Tennessee Graduate School of Medicine

Lead Sponsor

Trials

17

Recruited

1,400+

Shockwave Medical, Inc.

Industry Sponsor

Trials

38

Recruited

10,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07205068

Improved Outcomes With Pre-Procedure Shockwave IVL of ... Specifically, This study compares patients utilizing the Shockwave model (M5) Intravascular Lithotripsy (IVL) prior to standard arterial access ...

2. shockwavemedical.com shockwavemedical.com/disease-states/pad-ivl/pre-tavr/

Shockwave IVL For Pre-TAVR Outcome: Shockwave IVL provided effective calcium modification and allowed for desired transfemoral access for TAVR procedure. Series of four angiogram ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39477639/

Characteristics, Trends, and Outcomes of Intravascular ... IVL TAVR patients exhibited a higher burden of comorbidities and experienced more complications compared to non-IVL TAVR patients.

4. jvascsurg.org jvascsurg.org/article/S0741-5214(25)00960-7/fulltext

Mid-term outcomes of Shockwave intravascular lithotripsy ... Technical success was 99%. The target lesions were treated with IVL ONLY in 77% of cases, whereas IVL + STENT was employed in the remaining 23% of the cases ( ...

5. withpower.com withpower.com/trial/phase-aortic-valve-stenosis-9-2025-e4a12

Shockwave IVL for TAVR Access Site Complications Trial Overview The study tests if using the Shockwave M5 IVL Catheter to treat the artery before inserting a large tube (sheath) reduces complications compared ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12127253/

Shockwave lithotripsy-assisted TAVI in a patient with ... IVL-assisted transfemoral TAVI is a safe and effective strategy in patients with extensive iliofemoral calcifications.